Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

Last updated: April 7, 2025
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06166706
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  • Ages < 16
  • All Genders

Study Summary

Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • aged ≤ 16 years;

  • undergoing general anesthesia

  • airway management with tube or LMA; and

  • connected to mechanical ventilator . minimum duration of procedure: 15 minutes

Exclusion

Exclusion Criteria:

  • patients undergoing surgical procedures involving extra-corporal circulation;

  • patients receiving ventilation with high frequency jet ventilation or high frequencyoscillatory ventilation;

  • sedation without airway management in the form of a endotracheal tube or asupraglottic airway device; and

  • (rigid) bronchoscopic procedures with maintenance of spontaneous ventilation.

Study Design

Total Participants: 10000
Study Start date:
January 29, 2024
Estimated Completion Date:
January 07, 2026

Study Description

Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.

Objective

The aims of this study are to:

  • determine the incidence of PPCs in pediatric patients;

  • describe the practice of ventilatory support in children undergoing general anesthesia;

  • describe geo-economic differences/variations in ventilatory support and development of PPCs in children undergoing general anesthesia;

  • identify potentially modifiable factors that have independent associations with development of PPCs, hospital length of stay and pediatric intensive care unit (PICU) admittance; and

  • develop a risk score for the development of PPCs comparable to the ARISCAT score.

Study design Multicenter international observational cohort study. Study population Patients ≤16 years of age undergoing invasive ventilation for general anesthesia in the operating room.

Main study endpoints The primary endpoint is the incidence of PPCs. Secondary outcomes are the ventilator settings, ventilation parameters, length of hospital stay and PICU admittance.

Connect with a study center

  • Perth Children's Hospital

    Perth,
    Australia

    Site Not Available

  • IRCCS Istituto Giannina Gaslini

    Genoa,
    Italy

    Site Not Available

  • Amsterdam University Medical Centers

    Amsterdam, Please Select 1105AZ
    Netherlands

    Active - Recruiting

  • Universitatsspital Bern

    Bern,
    Switzerland

    Site Not Available

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